EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

Last updated 19 travnja 2024. Database contains 4917 unique substances/entries.

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Prikazano 1 - 50 od 4.917 rezultata.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU REACH: List of SVHC	EU_BA Directive 2000/54/EC
(2R, 3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (1R)-10-camphorsulfonate UK-103,449-BV	427-100-0	-	Acute Tox. 4; Eye Dam. 1; Skin Sens. 1			Details
(C16 or C18-n-alkyl)(C16 or C18-n-alkyl)ammonium 2-((C16 or C18-n-alkyl)(C16 or C18-n-alkyl)carbamoyl)benzenesulphonate OA 8523	402-460-1	-	Skin Irrit. 2; Skin Sens. 1			Details
(ethyl-1,2-ethanediyl)[-2-[[[(2-hydroxyethyl)methylamino]acetyl]-propyl]ω-(nonylphenoxy)poly]oxy-(methyl-1,2-ethanediyl) TFA-4713	418-960-8	-	Skin Corr. 1B; Skin Sens. 1			Details
(R)-1-cyclohexa-1,4-dienyl-1-methoxycarbonyl-methylammoniumchloride	444-320-2	-	Acute Tox. 4			Details
(R,S)-4-(4-dimethylamino-1-(4-fluorophenyl)-1-hydroxybutyl)3-(hydroxymethyl)benzonitrile hemisulfate	430-790-6	-	Acute Tox. 4; Eye Dam. 1; Skin Sens. 1			Details
(±)-4-(3-chlorophenyl)-6-[(4-chlorophenyl)hydroxy(1-methyl-1H-imidazol-5-yl)methyl]-1-methyl-2(1H)-quinolin	430-730-9	-	Eye Dam. 1			Details
1,6,7,8,9,14,15,16,17,17,18,18-Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene (''Dechlorane Plus''™) including any of its individual anti- and syn-isomers or any combination thereof	-	-		VPVB very Persistent and very Bioaccumulative (article 57e)		Details
2,2-dialkyl-4-hydroxymethyl1,3-dioxolane; reaction products with ethylene oxide (alkyl is C1-12 and the sum to C13, average degree of ethoxylation is 3,5)	430-580-4	-	Skin Irrit. 2			Details
2,5-dioxopyrrolidin-1-yl N-{[methyl[[2-(1-methylethyl)-4-thiazoly]methyl]amino]carbonyl}-L-Valinate	424-660-8	-	STOT RE 2; Eye Dam. 1; Skin Sens. 1			Details
2-(4-tert-Butylbenzyl)propionaldehyde and its individual stereoisomers show/hide 2-(4-tert-butylbenzyl)propionaldehyde EC / List no: 201-289-8 \| CAS no: 80-54-6 (2R)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - \| CAS no: 75166-31-3 (2S)-3-(4-tert-butylphenyl)-2-methylpropanal EC / List no: - \| CAS no: 75166-30-2	799-970-2	-		R Toxic for reproduction (article 57c)		Details
2-alkoyloxyethyl hydrogen maleate, where alkoyl represents (by weight 70 to 85 % unsaturated octadecoyl, 0.5 to 10 % saturated octadecoyl, and 2 to 18 % saturated hexadecoyl ATRAC 869	417-960-5	-	Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1			Details
2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in this Annex show/hide Metal salts of 2-ethylhexanoic acid EC / List no: - \| CAS no: - 2-ethylhexanoic acid EC / List no: 205-743-6 \| CAS no: 149-57-5	-	-	Repr. 1B			Details
4,4'-oxydianiline and its salts show/hide 4,4'-oxydianiline EC / List no: 202-977-0 \| CAS no: 101-80-4	-	-	Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3			Details
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated	-	-		ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
4-(3,4,5,6-tetramethyloctan-2-yl)phenol	-	-		R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health)		Details
4-Heptylphenol, branched and linear	-	-		ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
4-Nonylphenol, branched and linear	-	-		ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
4-Nonylphenol, branched and linear, ethoxylated	-	-		ENDE Endocrine disrupting properties (Article 57(f) - environment)		Details
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-		VPVB very Persistent and very Bioaccumulative (article 57e)		Details
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]	-	-		VPVB very Persistent and very Bioaccumulative (article 57e)		Details
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane	-	-		VPVB very Persistent and very Bioaccumulative (article 57e)		Details
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)	441-550-5	-	Self-react. C; Carc. 2			Details
6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid	701-162-1	-	Repr. 1B			Details
6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts	701-271-4	-	Repr. 1B; Eye Irrit. 2			Details
A 2:1:1 mixture of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')-N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.	402-850-1	-	Eye Dam. 1			Details
A mixture of isomers of iron (1:2) complexes of a mixture of: isomers of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-(5-amino-sulfonyl-2-hydroxyphenylazo)benzene (n=2,5,6); isomers of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-[4-(4-nitro-2-sulfophenylamino)phenylazo]benzene (n=2,5,6) BROWN JR 543	414-150-3	-	Skin Sens. 1			Details
A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable) BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763	404-540-1	-	Skin Sens. 1			Details
A mixture of: ((Z)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid; di-((E)-3,7-dimethyl-2,6-octadienyl) butandioate; di-((Z)-3,7-dimethyl-2,6-octadienyl) butandioate; (Z)-3,7-dimethyl-2,6-octadienyl butandioate; ((E)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid MS6119	415-190-4	-	Skin Sens. 1			Details
A mixture of: (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)tetradec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)tetradec-4-enoate HOSTACOR 4205 CONC.; HOSTACOR V 4205	413-500-2	-	Skin Irrit. 2; Eye Dam. 1			Details
A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione; a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione BLENDUR I VP KU 3-4519	421-550-1	-	Carc. 1B; Repr. 1B; Skin Sens. 1			Details
A mixture of: 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-tridecafluorooctyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-heptdecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl) 12-(1''H,1''H,2''H,2''H-pentacosafluorotetradecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl) 12-(1''H,1''H,2''H,2''H-heptadecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl) 12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate HFR-990	423-180-6	-	STOT RE 2			Details
A mixture of: 2-(9-methyl-1,3,8,10-tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-anthra[2,1,9-def: 6,5,10-d'e'f']diisoquinolin-2-ylethansulfonic acid; potassium 2-(9-methyl-1,3,8,10-tetraoxo-2,3,9,10-tetrahydro-(1H,8H)-anthra[2,1,9-def: 6,5,10-d'e'f']diisoquinolin-2-ylethansulfate PIGMENTADDITIV P	411-310-4	-	Eye Dam. 1			Details
A mixture of: 3-(N-(3-dimethylaminopropyl)-(C4-8)perfluoroalkylsulfonamido)propionic acid; N-[dimethyl-3-(C4-8-perfluoroalkylsulfonamido)propylammonium propionate; 3-(N-(3-dimethylpropylammonium)-(C4-8)perfluoroalkylsulfonamido)propionic acid propionate ACRYLSKUM; T-2816 FOAMER	407-810-7	-	STOT RE 2			Details
A mixture of: 3-cyano-5-(2-cyano-4-nitro-phenylazo)-2-(2-hydroxyethylamino)-4-methyl-6-[3-(2-phenoxyethoxy)propylamino]pyridine; 3-cyano-5-(2-cyano-4-nitro-phenylazo)-6-(2-hydroxyethylamino)-4-methyl-2-[3-(2-phenoxyethoxy)propylamino]pyridine; 3-cyano-5-(2-cyano-4-nitro-phenylazo)-2-amino-4-methyl-6-[3-(3-hydroxypropoxy)propylamino]pyridine; 3-cyano-5-(2-cyano-4-nitro-phenylazo)-6-amino-4-methyl-2-[3-(3-methoxypropoxy)propylamino]pyridine DISPERSIONSROT 2754	411-880-4	-	Skin Sens. 1			Details
A mixture of: 4,4',4''-[(2,4,6-trioxo-1,3,5(2H,4H,6H)-triazine-1,3,5-triyl)tris[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)iminocarbonyloxy-2,1-ethanediyl(ethyl)amino]]trisbenzenediazoniumtri[bis(2-methylpropyl)naphthalenesulfonate]; 4,4',4'',4'''-[[5,5'-[carbonylbis[imino(1,5,5-trimethyl-3,1-cyclohexanediyl)methylene]]-2,4,6-trioxo-1,3,5(2H,4H,6H)-triazine-1,1',3,3'-tetrayl]tetrakis[methylene(3,5,5-trimethyl-3,1-cyclohexanediyl)iminocarbonyloxy-2,1-ethanediyl(ethyl)amino]]tetrakisbenzenediazoniumtetra[bis(2-methylpropyl)naphthalenesulfonate] 34 DIAZO	417-080-1	-	Self-react. D; Skin Sens. 1			Details
A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS	417-470-1	-	Muta. 2; Skin Sens. 1			Details
A mixture of: calcium bis(C10-14 branched alkyl salicylate); calcium bis(C18-30-alkyl salicylate); calcium C10-14 branched alkylsalicylato-C18-30-alkyl salicylate; calcium bis (C10-14 branched alkyl phenolate); calcium bis (C18-30-alkyl phenolate); calcium C10-14 branched alkylphenolato-C18-30-alkyl phenolate; C10-14 branched alkyl phenol; C18-30-alkyl phenol SP 7077	430-180-1	-	Skin Irrit. 2			Details
A mixture of: dicalcium (bis(2-hydroxy-5-tetra-propenylphenylmethyl)methylamine)dihydroxide; tri-calcium (tris(2-hydroxy-5-tetra-propenylphenylmethyl)methylamine)tri-hydroxide; poly[calcium ((2-hydroxy-5-tetrapropenyl-phenylmethyl)methylamine)hydroxide] OLOA 224 (OIL FREE)	420-470-4	-	Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1			Details
A mixture of: monosodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; disodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; trisodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate; tetrasodium 4-((4-(5-sulfonato-2-methoxyphenylamino)-6-chloro-1,3,5-triazine-2-yl)amino)-2-((1,4-dimethyl-6-oxido-2-oxo-5-sulfonatomethyl-1,2-dihydropyridine-3-yl)azo)benzenesulfonate REACTIVE YELLOW FC 75560	419-450-8	-	Skin Sens. 1			Details
A mixture of: N-[3-hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide; N-[2,3-bis-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide; methacrylamide; 2-methyl-N-(2-methylacryloylaminomethoxymethyl)acrylamide; N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide VERNETZER TMAG	412-790-8	-	Carc. 1B; Muta. 2; STOT RE 2			Details
A mixture of: sodium/potassium (3-(4-(5-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-2-methoxy-3-sulfonatophenylazo)-2-oxidophenylazo)-2,5,7-trisulfonato-4-naphtholato)copper(II); sodium/potassium (3-(4-(5-(5-chloro-4,6-difluoropyrimidin-2-ylamino)-2-methoxy-3-sulfonatophenylazo)-2-oxidophenylazo)-2,5,7-trisulfonato-4-naphtholato)copper(II) DRIMAREN NAVY R-GRL; NAVY 14 08 723	407-100-7	-	Skin Sens. 1			Details
A mixture of: trisodium 5-{4-chloro-6-[2-(2,6-dichloro-5-cyanopyrimidin-4-ylamino)-propylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalene-2-ylazo)-naphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[2-(2,6-dichloro-5-cyanopyrimidin-4-ylamino)-1-methyl-ethylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalene-2-ylazo)-naphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[2-(4,6-dichloro-5-cyanopyrimidin-2-ylamino)-propylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate; trisodium 5-{4-chloro-6-[2-(4,6-dichloro-5-cyanopyrimidin-2-ylamino)-1-methyl-ethylamino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate RED MDO 358	414-620-8	-	Eye Dam. 1; Skin Sens. 1			Details
A mixture of: α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene); α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene) EVERSORB 80; TINUVIN 1130; TINUVIN 213	400-830-7	-	Skin Sens. 1			Details
A mixture of: α-[3-(3-mercaptopropanoxycarbonylamino)methylphenylaminocarbonyl]-ω-[3-(3-mercaptopropanoxycarbonylamino)methylphenylaminocarbonyloxy]-poly-(oxyethylene-co-oxypropylene); 1,2-(or 1,3-)bis[α-(3-mercaptopropanoxycarbonylamino)methylphenylaminocarbonyl)-ω-oxy-poly(oxyethylene-co-oxypropylene)]-3-(or 2-)propanol; 1,2,3-tris[α-(3-mercaptopropanoxycarbonyl-amino)methylphenylaminocarbonyl)-ω-oxy-poly-(oxyethylene-co-oxypropylene)]propane] P2-800; P2-935LV	415-870-0	-	Skin Sens. 1			Details
Absettarov	-	-			V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.	Details
Acanthamoeba castellani	-	-			P Parasites	Details
Actinomadura madurae	-	-			B Bacteria and similar species	Details
Actinomadura pelletieri	-	-			B Bacteria and similar species	Details
Actinomyces gerencseriae	-	-			B Bacteria and similar species	Details
Actinomyces israelii	-	-			B Bacteria and similar species	Details

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EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

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Last updated 19 travnja 2024. Database contains 4917 unique substances/entries.

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